Simvastatin

Product NDC
63304-793
11-digit product format
633040793
Labeler code
63304
Product ID
63304-793_d005a31b-31ba-400e-a75c-99e6adf745bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076285
Marketing category
ANDA
Marketing start
2006-12-20
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63304-793IInactivated by FDA2026-10-12
excluded packagepackage63304-79363304-793-10IInactivated by FDA2026-10-12
excluded packagepackage63304-79363304-793-30IInactivated by FDA2026-10-12
excluded packagepackage63304-79363304-793-50IInactivated by FDA2026-10-12
excluded packagepackage63304-79363304-793-90IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 114 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-793-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-793-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-793-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-793-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-793-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-793-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-793-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-793-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-793-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-793-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-793-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-793-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-793-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-793-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-793-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-793-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-793-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-793-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-793-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-793-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-793-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-793-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-793-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-793-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-793-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-793-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-793-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-793-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-793-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-793-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-793-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-793-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-793-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-793-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-793-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-793-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-793-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-793-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-793-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-793-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-793-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-793-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-793-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-793-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-793-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-793-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-793-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-793-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076285-001SIMVASTATINSIMVASTATIN5MGTABLET / ORAL2006-12-20
A076285-002SIMVASTATINSIMVASTATIN10MGTABLET / ORAL2006-12-20
A076285-003SIMVASTATINSIMVASTATIN20MGTABLET / ORAL2006-12-20
A076285-004SIMVASTATINSIMVASTATIN40MGTABLET / ORAL2006-12-20
A076285-005SIMVASTATINSIMVASTATIN80MGTABLET / ORAL2006-06-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076285-001SIMVASTATIN5MGTABLET / ORAL2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076285-002SIMVASTATIN10MGTABLET / ORAL2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076285-003SIMVASTATIN20MGTABLET / ORAL2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076285-004SIMVASTATIN40MGTABLET / ORAL2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076285-005SIMVASTATIN80MGTABLET / ORAL2006-06-2303ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-793-10Simvastatin1000 in 1 BOTTLETABLET, FILM COATED100010
63304-793-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED3010
63304-793-50Simvastatin50 in 1 BOTTLETABLET, FILM COATED5010
63304-793-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-793-10EA - Each63304-79385c05780-6c23-4d41-bc09-d8538e51aaf912012-07-24
63304-793-50EA - Each63304-79329523199-713d-4830-947d-2f662e72863f12012-07-24
63304-793-90EA - Each63304-7932af0569e-c709-46ad-a18a-1e0732bbd0e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-793SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]10Legacy NDC, 4 package rows20140429_cdb54447-86a5-4924-a7de-ec170f86651d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNcdb54447-86a5-4924-a7de-ec170f86651d10
312961simvastatin 20 MG Oral TabletPSNcdb54447-86a5-4924-a7de-ec170f86651d10
198211simvastatin 40 MG Oral TabletPSNcdb54447-86a5-4924-a7de-ec170f86651d10
312962simvastatin 5 MG Oral TabletPSNcdb54447-86a5-4924-a7de-ec170f86651d10
200345simvastatin 80 MG Oral TabletPSNcdb54447-86a5-4924-a7de-ec170f86651d10
314231simvastatin 10 MG Oral TabletSCDcdb54447-86a5-4924-a7de-ec170f86651d10
312961simvastatin 20 MG Oral TabletSCDcdb54447-86a5-4924-a7de-ec170f86651d10
198211simvastatin 40 MG Oral TabletSCDcdb54447-86a5-4924-a7de-ec170f86651d10
312962simvastatin 5 MG Oral TabletSCDcdb54447-86a5-4924-a7de-ec170f86651d10
200345simvastatin 80 MG Oral TabletSCDcdb54447-86a5-4924-a7de-ec170f86651d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-793-10633040793101000 in 1 BOTTLEHistorical
63304-793-306330407933030 in 1 BOTTLEHistorical
63304-793-506330407935050 in 1 BOTTLEHistorical
63304-793-906330407939090 in 1 BOTTLEHistorical